Helping Those With Mental Illness Quit Smoking

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01783912
First received: January 22, 2013
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

This study tests whether pre-cessation interventions known to be effective in the general population will increase acceptance of evidence-based treatment, engagement and compliance with that treatment and initial quitting success. One hundred and seventy two patients will be recruited from 13 Community Support Programs (CSPs). CSPs provide community based care to those diagnosed with persistent and serious mental illness. All participants will receive two group sessions (40 minutes each) modeled after "Kicking Butts", a group-based quitting preparation program used for the past four years in two Milwaukee CSP programs run by Wisconsin Community Services. Individuals will then be randomly assigned to the experimental and control conditions (n=86 each). Experimental subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each). Attention control subjects will also receive four individual sessions of the same duration. However their individual sessions' content will be a discussion of the personal relevance of the group material and will not include any of the preparatory interventions. Data will be collected via brief surveys taken pre-intervention, at the end of the last individual session, and three months later and from a database provided by the Wisconsin Tobacco Quit Line (WTQL).


Condition Intervention Phase
Smoking
Nicotine Dependence
Mental Disorders
Behavioral: Cognitive / Motivational Individual Sessions
Behavioral: Attention Control Individual Sessions
Drug: Nicotine Patch
Behavioral: Group Curriculum
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Preparing Those With Significant and Persistent Mental Illness to Quit Smoking

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Acceptance of Wisconsin Tobacco Quit Line services [ Time Frame: 4-6 weeks after study enrollment ] [ Designated as safety issue: No ]
    The primary outcome is participant acceptance of evidence based treatment through the WTQL at the end of the last individual session.


Estimated Enrollment: 272
Study Start Date: December 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive/Motivational Intervention Group

This arm of the project will address the following questions:

After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?

After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?

Behavioral: Cognitive / Motivational Individual Sessions
Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).
Drug: Nicotine Patch
Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks.
Behavioral: Group Curriculum
Everyone to be put into the experimental or active comparator group will attend 2 group meetings over two weeks each of which lasts 40 minutes. Experience with the Kicking Butts program indicates that this duration is well tolerated by this population. The content of these two group meetings is based on the Kicking Butts program. The Kicking Butts program was initially developed as a cessation intervention, but consistent with the literature about the need to prepare this population to make a quit attempt, has evolved to emphasize preparation for quitting. Topics addressed include the health consequences of smoking, reasons to quit and methods of quitting.
Active Comparator: Attention Control Group

This arm of the project will address the following question:

After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?

After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?

Behavioral: Attention Control Individual Sessions
Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking.
Behavioral: Group Curriculum
Everyone to be put into the experimental or active comparator group will attend 2 group meetings over two weeks each of which lasts 40 minutes. Experience with the Kicking Butts program indicates that this duration is well tolerated by this population. The content of these two group meetings is based on the Kicking Butts program. The Kicking Butts program was initially developed as a cessation intervention, but consistent with the literature about the need to prepare this population to make a quit attempt, has evolved to emphasize preparation for quitting. Topics addressed include the health consequences of smoking, reasons to quit and methods of quitting.
No Intervention: Motivated Smokers Comparison Group

This arm of the project will address the following question:

Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?

Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?

Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • current smoker (smoking daily or smoking at least 10 cigarettes per week) (use of other tobacco products permitted such as chew and snuz in addition to smoking)
  • not willing to make a quit attempt
  • willingness to use the nicotine patch
  • plans to remain in the area for the next five four months.

Exclusion Criteria:

  • current use of any cessation medicine (nicotine patch, nicotine gum, nicotine lozenge, nicotine inhaler, nicotine nasal spray, bupropion, Wellbutrin, Zyban,Chantix or varenicline)
  • previous serious skin reaction or other allergic reaction to using the nicotine patch
  • stroke, heart attack or abnormal electrocardiogram in past four weeks
  • pregnancy, plans to get pregnant or nursing
  • exclusive use of other tobacco products (non-smoker tobacco user)
  • having a court-ordered guardian, or an activated power of attorney for health or observation by researchers during the consent procedure that suggests diminished decision making capacity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783912

Locations
United States, Wisconsin
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, United States, 53711
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Bruce Christiansen, PhD University of Wisconsin School of Medicine and Public Health, Center for Tobacco Research and Intervention
  More Information

Additional Information:
No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01783912     History of Changes
Other Study ID Numbers: IRB00001316
Study First Received: January 22, 2013
Last Updated: May 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Smoking
Nicotine Dependence
Mental Disorders

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Tobacco Use Disorder
Smoking
Schizophrenia and Disorders with Psychotic Features
Substance-Related Disorders
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014